Who is the manufacturer of Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Surgical Instrument and Savings Inc (Dba Medline Renewal) filed the 510(k) submission for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (K201699).

What is the FDA product code for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

NLF. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

510(k) clearance (submission type: Special).

What are the predicate devices for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors (models MAXA, MAXAL, MAXP, and MAXI) (K181738).

Who can help prepare an FDA 510(k) submission like Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

K201699 · Surgical Instrument and Savings Inc (Dba Medline Renewal) · NLF · Jul 22, 2020 · Cardiovascular

Device Facts

Record ID	K201699
Device Name	Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Applicant	Surgical Instrument and Savings Inc (Dba Medline Renewal)
Product Code	NLF · Cardiovascular
Decision Date	Jul 22, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2700
Device Class	Class 2

Indications for Use

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. This device is for prescription use only.

Device Story

Reprocessed transmissive SpO2 sensor; utilizes red and infrared LEDs as light sources; photodiode photodetector senses light transmission through tissue; detects time-varying changes in optical properties due to pulsatile blood flow. Used in hospitals, hospital-type facilities, and intra-hospital transport; operated by clinicians. Connects to Nellcor OxiMax or compatible pulse oximeters. Oximeter processes electrical signals via algorithm to output real-time SpO2, pulse rate, and pulse amplitude. Provides continuous monitoring to assist clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Clinical trial conducted under K181738 included 10 healthy adult volunteers (ages 25-36). Study followed ISO 80601-2-61:2011 and ISO 14155:2011. Primary endpoint: SpO2 accuracy comparison. Results: Accuracy of 2% for 70%-100% SpO2 range, passing the Arms specification of 3% under steady-state and non-motion conditions.

Technological Characteristics

Transmissive SpO2 sensor; materials include adhesive bandage, cable, and connector. Sensing principle: dual-wavelength (red/infrared) LED light source and photodiode detector. Connectivity: wired to Nellcor-compatible pulse oximeter. Reprocessed device; non-sterile. Performance specs: SpO2 range 70-100% (±2 digits), pulse rate 20-250 bpm (±3 digits).

Indications for Use

Indicated for single patient use for continuous non-invasive arterial oxygen saturation and pulse rate monitoring in adult patients (> 40 kg). Prescription use only.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors (models MAXA, MAXAL, MAXP, and MAXI) (K181738)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". Surgical Instrument and Savings Inc (dba Medline ReNewal) % Stephanie Mays Sr. Regulatory Affairs Specialist, Quality Assurance and Regulatory Affairs Surgical Instrument Service and Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond, Oregon 97756 Re: K201699 Trade/Device Name: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (model: MAXNAR) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: June 19, 2020 Received: June 22, 2020 Dear Stephanie Mays: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201699 Device Name Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR Indications for Use (Describe) The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | OEM Device Modela | Device Name | OEM | |------------------------------------------|------------------------------------------------------------------------------------------|----------------------------| | MAXNAR | Nellcor OxiMax Pulse Oximeter Sensor (Adult SpO2 Sensor > 40 kg; woven bandage) | Nellcor Puritan Bennett | | a OEM = original equipment manufacturer. | | | K201699 Reprocessed Nellcor OxiMax SpO2 Sensor included in Submission: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. Special 510(k) Notification Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR # K201699 Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92. | Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal) 1500 NE Hemlock Ave., Redmond, OR 97756 | | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--| | Prepared by/Contact Name | Stephanie Boyle Mays Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs P: 541-516-4205 • F: 541-923-3375 • E:smays@medline.com | | | | Date Prepared | June 19, 2020 | | | | Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR | | | | Common or usual name | Oximeter, reprocessed | | | | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | | | | Regulatory Class: | Class II | | | | Product Code: | NLF | | | | 510(k) number: | K181738 (March 22, 2019) | | | Predicate Device | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA, MAXAL, MAXP, and MAXI | | | | Common or usual name | Oximeter, reprocessed | | | | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | | | | Regulatory Class: | Class II | | | | Product Code: | NLF | | | | Panel: | Cardiovascular/anesthesiology | | | | Manufacturer: | Surgical Instrument Service and Savings (dba Medline ReNewal) 1500 NE Hemlock Ave., Redmond, OR 97756 | | | Statement of Indications for Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only. | | | | Device Description | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile | | | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows two logos side by side. The first logo is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in blue letters next to it. The second logo is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. Medline ReRenewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR | Statement of Intended Use | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with adult patients in hospitals, hospital-type facilities and intra-hospital transport. The device is for prescription use only. | |------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological (including features, materials and principles of operation) | The technological characteristics and the fundamental scientific technology of the subject device are similar to the predicate devices. The proposed device is a reprocessed Nellcor OxiMax SpO2 Sensor as are the devices within the scope of predicate K181738. The proposed device uses use an adhesive bandage, light source (LEDs), photodetector (Faraday cage/photodiode), cable, and connector in the same manner as the predicate devices. The predicate devices were used to support intended use, technological characteristics, and performance specifications. (Also see comparison of technological features in the Summary Table) | | Performance Testing Nonclinical Tests | The functional characteristics of the predicate and proposed devices were examined in K181738 and were evaluated in accordance with Pulse Oximeters - Premarket Notifications Submissions [510(k)] Guidance for Industry and Food and Drug Administration Staff (March 4, 2013). Testing included: • Biocompatibility: cytotoxicity, sensitization, irritation; acute systemic toxicity • Disinfection • Shelf Life • Electrical • Performance testing: • tissue heating • pulse rate accuracy • active element assessment • adhesive peel and • environment (extreme heat and operating conditions) • Cleaning: • visual inspection; • cleaning efficacy (residual protein and residual hemoglobin). | | Performance Testing Clinical Tests | The purpose of the clinical trial in predicate submission K181738 (which included proposed device Model MAXNAR) was to perform an oxygen saturation (SpO2) accuracy comparison. The study was conducted in accordance with CFR for Non-significant Risk Investigational Studies, following ISO 14155:2011 Clinical Investigation of medical devices for human subjects – Good clinical practice as appropriate and the pulse oximeter guidelines of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections and Pulse Oximeters - Premarket Notifications Submissions [510(k)] Guidance for Industry and Food and Drug Administration Staff (March 4, 2013). After Institutional Review Board Approval, 10 healthy adults volunteer subjects (ages 25 to 36 yr.; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4) were included in the study which was conducted from May 9 to May | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a blue star. The second logo is for ReNewal Full Circle Reprocessing, with the word "ReNewal" in green and the words "Full Circle Reprocessing" in blue below it. | Performance Testing Clinical Tests (concluded) | SpO2 accuracy of the proposed devices. The proposed devices achieved an accuracy of 2% for 70% - 100% SpO2. The study concluded that the SpO2 accuracy performance of the proposed devices passed the Arms specification of 3% under steady state and non-motion conditions for the range of 70% to 100%. | | | |--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Device Model | MAXNAR | | | | Summary Table: Predicate (unmodified) and Proposed (modified) Medline ReNewal Reprocessed Nellcor OxiMax SpO2 sensor comparison. | | | | | | Predicate | Proposed | | | Device Characteristics | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, MAXNAR | Comparison | | 510(k) Number | K181738 | TBD | N/A | | Common Name | Oximeter | Oximeter | Same | | Regulation No. | 870.2700 | 870.2700 | Same | | Product Code | NLF | NLF | As stated | | Models | MAXA, MAXAL, MAXP, and MAXI | MAXNAR | As stated | | Indications for Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models MAXA, MAXP and MAXI are indicated for single patient use when continuous non- invasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use. These devices are for prescription use only. | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only. | Same | | Intended Use | The reprocessed Nellcor OxiMax SpO2 Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with pediatric and adult patients in hospitals, | The reprocessed Nellcor OxiMax SpO2 Sensor is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with adult patients in hospitals, hospital-type | Same | | | Predicate | Proposed | | | Device Characteristics | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, MAXNAR | Comparison | | Intended Use (concluded) | hospital-type facilities, and intra-hospital transport. These devices are for prescription use only. | facilities, and intra-hospital transport. This device is for prescription use only. | Same | | Comparison of technological features | The reprocessed Nellcor OxiMax SpO2 Sensors measure functional oxygen saturation non- invasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsatile blood flow. Red and infrared light-emitting diodes (LEDS) are utilized as light sources. A photodiode acting as a photo detector senses the signal strengths of the two wavelengths of light, which vary with the amount of light transmitted through the tissue. The pulse oximeter receives this electrical information from the sensor and processes the information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude. | The reprocessed Nellcor OxiMax SpO2 Sensor measures functional oxygen saturation non- invasively, via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsatile blood flow. Red and infrared light-emitting diodes (LEDS) are utilized as light sources. A photodiode acting as a photo detector senses the signal strengths of the two wavelengths of light, which vary with the amount of light transmitted through the tissue. The pulse oximeter receives this electrical information from the sensor and processes the information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude. | Same | | Intended patient population | Adult (MAXA, MAXAL), Pediatric (MAXP), Infant (MAXI) | Adult | Same as Predicate MAXA, MAXAL | | Device Characteristics | Predicate Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors | Proposed Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, MAXNAR | Comparison | | Patient Weight Range | • > 30 kg = adult (MAXA, MAXAL) • 10 - 50 kg = pediatric (MAXP) • 3 - 20 kg = infants (MAXI) | • > 40 kg = adult | Same Within weight range of Predicate MAXA, MAXAL | | Application site | • Finger = MAXA, MAXL, MAXP • Toe or digit of similar size = MAXI | • Finger | Same as predicate MAXA, MAXAL, MAXP | | Single Use | Yes | Yes | Same | | Use Environment | Hospitals, hospital-type facilities, and intra-hospital transport | Hospitals, hospital-type facilities, and intra-hospital transport | Same | | Measurement Parameter | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Same | | Monitor system compatibility | Nellcor OxiMax and Nellcor compatible pulse oximeters | Nellcor OxiMax and Nellcor compatible pulse oximeters | Same | | Specified SpO2 measurement range | 70% - 100% (MAXA, MAXAL, MAXP, MAXI) | 70% - 100% | Same | | SpO2 accuracy | 70% - 100% ± 2 digits in adults (MAXA, MAXAL, MAXP, MAXI) | 70% - 100% ± 2 digits in adults | Same | | Pulse rate measurement range (bpm) | 20 - 250 bpm (MAXA, MAXAL, MAXP, MAXI) | 20 - 250 bpm | Same | | Pulse rate accuracy (bpm) | 20 - 250 ± 3 digits (MAXA, MAXAL, MAXP, MAXI) | 20 - 250 ± 3 digits | Same | | Temperature Operational/ Storage | Operational = 5°C - 40°C Storage = 20°C - 60°C | Operational = 5°C - 40°C Storage = 20°C - 60°C | Same | | Relative humidity | 15% - 95% no…

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

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Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

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